Skip to content
Home
About IEN-IBD
Board of Directors
Home
About IEN-IBD
Board of Directors
Contact us
Step
1
of
2
50%
Unique No
Introduction
Welcome to the official page for the Clinical Practice Guidelines on Best Practices for the use of small molecules and anti-IL-23p19 inhibitors in the treatment of ulcerative colitis and Crohn's disease. This initiative, led by the Asia Pacific Association of Gastroenterology (APAGE) Working Group for IBD in collaboration with the Asian Education Network for IBD (AEN-IBD), aims to standardize care, improve patient outcomes, and address the unique challenges faced by healthcare professionals in the Asia-Pacific region.
About the Consensus
The primary goal of this consensus meeting is to develop comprehensive and evidence-based Clinical Practice Guidelines for the use of small molecules and anti-IL-23p19 inhibitors in the treatment of ulcerative colitis and Crohn's disease. The consensus will be developed using the modified Delphi method and the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system to ensure a rigorous and transparent process.
What You Need to Do
We are currently initiating the first round of voting for the consensus. There are a total of 33 statements, please review them and rate your agreement on each statement. The agreement level will be as follows: 1 = Reject Completely 2 = Reject with reservation 3 = Accept with major reservation 4 = Accept with some reservation 5 = Accept completely A statement will only be accepted if more than 80% of the voting panel voted 4 or 5. Please leave your comments, if any, for each statement in the box provided. Your feedback is essential for refining and finalizing these guidelines. When you are ready to start the voting, click on the "Start" button. The voting process is estimated to take approximately 30 minutes. Voting will be anonymous. Your identity will not be linked to your individual votes, and your voting choices will remain confidential. Thank you for your valuable contribution to this important initiative. As an esteemed member of the voting panel, your participation is crucial in shaping these guidelines.
Statement 1
(Required)
Guselkumab, Mirikizumab and Risankizumab can be used as induction and maintenance therapy in advanced therapy naïve and experienced adult patients with moderate-to-severe ulcerative colitis (UC) and Crohn's disease (CD).
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 1
Statement 2a
(Required)
The induction dose of Risankizumab in UC is 1200 mg i.v. at Weeks 0, 4, and 8, followed by a maintenance dose of 180 or 360 mg SC at Week 12 and every 8 weeks thereafter
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 2a
Statement 2b
(Required)
The induction dose of Risankizumab in CD is 600 mg i.v. at Weeks 0, 4, and 8, followed by a maintenance dose of 360 mg SC at Week 12 and every 8 weeks thereafter
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 2b
Statement 3a
(Required)
The induction dose of Mirikizumab in UC is 300 mg IV at weeks 0, 4, and 8 followed by a maintenance dose of 200 mg SC at week 12, and every 4 weeks thereafter
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 3a
Statement 3b
(Required)
The induction dose of Mirikizumab in CD is 900mg IV at Weeks 0, 4, and 8 followed by a maintenance dose of 300 mg SC at week 12, and every 4 weeks thereafter
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 3b
Statement 4a
(Required)
The IV induction dose for Guselkumab in both UC and CD is 200 mg IV at Weeks 0, 4, and 8, followed by a maintenance dose of 200 mg SC at Week 12 and every 4 weeks thereafter or 100 mg SC at Week 16, and every 8 weeks thereafter.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 4a
Statement 4b
(Required)
The SC induction dose for Guselkumab in both UC and CD is 400mg at Weeks 0, 4 and 8 followed by a maintenance dose of 200 mg SC at Week 12 and every 4 weeks thereafter or 100 mg SC at Week 16, and every 8 weeks thereafter
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 4b
Statement 5
(Required)
Rizankizumab and guselkumab are superior to ustekinumab in terms of endoscopic healing
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 5
Statement 6
(Required)
Rizankizumab and guselkumab have shown efficacy even in patients who are refractory to Ustekinumab
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 6
Statement 7
(Required)
There is limited data on the efficacy of rizankizumab, mirikizumab and guselkumab in extraintestinal manifestations (EIMs).
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Statement 7
Statement 8
(Required)
There is limited data on the efficacy of rizankizumab, mirikizumab and guselkumab in perianal fistulising Crohn’s disease
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 8
Statement 9a
(Required)
The safety and efficacy of risankizumab, mirikizumab and guselkumab in paediatric patients with IBD have not been established.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 9a
Statement 9b
(Required)
There is limited data on the safety of Risankizumab, mirikizumab and guselkumab in pregnant IBD patients.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 9b
Statement 10
(Required)
Risankizumab, mirikizumab and guselkumab have excellent safety profiles with minimal side effects and no special contra-indications or black box warning
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 10
Statement 11
(Required)
Tofacitinib and filgotinib can be used for induction and maintenance of remission in patients with moderate-to-severe UC who are refractory or intolerant to conventional or advanced therapies.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 11
Statement 12
(Required)
Upadacitinib can be used as induction and maintenance therapy in patients with moderate to severe UC and Crohn’s disease who are refractory or intolerant to conventional or advanced therapies.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 12
Statement 13
(Required)
The recommended dose for tofacitinib in moderate-to-severe UC is 10 mg twice daily for 8 weeks in the induction phase, followed by 5 mg twice daily in the maintenance phase.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 13
Statement 14
(Required)
While the standard dose of filgotinib is 200mg once daily as an induction and maintenance therapy, the dose should be reduced in patients at risk of venous thromboembolism, malignancy, or major cardiovascular disease where possible.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 14
Statement 15
(Required)
The recommended UC induction dose for upadacitinib is 45 mg daily for 2 months followed by 30 mg or 15 mg daily for maintenance. In CD, the induction dose is 45 mg a day for 3 months followed by 30 mg or 15 mg a day for maintenance.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 15
Statement 16
(Required)
Upadacitinib can be considered in patients who are refractory to tofacitinib
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 16
Statement 17
(Required)
There is limited data to support the use of upadacitinib in fistulizing and perianal CD.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 17
Statement 18
(Required)
Upadacitinib can be used in IBD patients with concomitant axial spondylopathy and possibly in patients with peripheral arthropathy
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 18
Statement 19
(Required)
Cautious use of tofacitinib and upadacitinib as a first-line agent in patients at risk for adverse cardiovascular outcomes (those aged 65 years or older, current or previous long-term smokers, a history of cardiovascular disease, venous thromboembolic disease and a history of cancer).
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 19
Statement 20
(Required)
To minimise the risk of herpes zoster infection associated with JAK inhibitor, vaccination against herpes zoster is advised.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 20
Statement 21
(Required)
The safety and efficacy of Upadacitinib, filgotinib and tofacitinib in paediatric IBD patients have not been established.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 21
Statement 22
(Required)
JAKi are contraindicated in pregnancy and breastfeeding.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 22
Statement 23
(Required)
Tofacitinib and upadacitinib may be considered for hospitalized patients with ASUC.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 23
Statement 24
(Required)
Etrasimod and ozanimod can be used for both induction and maintenance therapy in adults with moderately to severely active UC, who have had inadequate response, loss of response or intolerant to conventional or advanced therapies.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 24
Statement 25
(Required)
The induction dose of etrasimod for UC is 2 mg orally once daily, with maintenance continuing at the same dose.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 25
Statement 26
(Required)
The induction dose of ozanimod is 0.23 mg daily on Days 1–4, 0.46 mg daily on Days 5–7, and 0.92 mg daily from Day 8 and thereafter.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 26
Statement 27a
(Required)
The safety and effectiveness of etrasimod and ozanimod in paediatric patients have not been established.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 27a
Statement 27b
(Required)
Etrasimod and ozanimod should be avoided in pregnant patients as their safety in pregnancy has not been established.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 27b
Statement 28
(Required)
There is limited data for the use of etrasimod and ozanimod in extraintestinal manifestations (EIMs).
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 28
Statement 29a
(Required)
Etrasimod and ozanimod have not been associated with a significant increased risk of serious infections, including herpes zoster and tuberculosis reactivation.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 29a
Statement 29b
(Required)
Etrasimod and ozanimod have not been associated with Progressive Multifocal Leukoencephalopathy in IBD patients.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 29b
Statement 30
(Required)
Etrasimod and ozanimod should not be used in patients with a history of significant cardiovascular disease and its complications.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 30
Statement 31
(Required)
Patients who have been escalated to Advanced therapies can consider stopping 5ASAs
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 31
Statement 32a
(Required)
We are unable to recommend the concomitant use of immunomodulators with tofacitinib, upadacitinib and S1P receptor modulators.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 32a
Statement 32b
(Required)
There is no evidence of additional benefit or increased risk when combining p19 IL-23 inhibitors or filgotinib with immunomodulators.
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 32b
Statement 33
(Required)
Concurrent use of two or more advanced treatments (i.e. biologic therapies and/or advanced small molecules) may be considered for selected patients with refractory active IBD or those who have active co-existing extraintestinal manifestations (EIMs) or other immune-mediated inflammatory disease (IMIDs).
Reject completely
Reject with reservation
Accept with major reservation
Accept with reservation
Accept completely
Comments for Statement 33